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510(k) K042122

SMARTINFUSER PAINPUMP by Precise Medical Products — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2004
Date Received
August 6, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Elastomeric
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Precise Medical Products

  • K061409 — SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET (June 16, 2006)

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  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)
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  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
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